Oct 15, 2019

On October 4th, 2019 the Medical Devices Coordination Group (MDCG) issued a guidance document on the validity of certificates issued under the (Active Implantable) Medical Devices Directive (AIMDD), following the Date of Application of the Medical Devices Regulation (EU) 2017/745 (MDR). These so-called “legacy devices” can be placed on the market until the certificate expires or until May 26, 2024, whichever comes first.

According to the new guidance, manufacturers can place legacy devices on the market under specific conditions, some of which are specified by MDCG. The Notified Body that issued the certificate must remain designated for the AIMDD and MDD for as long as it wants to keep up its surveillance activities. Member States must therefore keep monitoring these Notified Bodies for the Directives. Manufacturers must of course have an agreement with their AIMDD/MDD Notified Bodies to ensure ongoing surveillance activities. An important condition for this would of course be the Notified Body’s continuation of their activities.

Questions about Notified Body capacity for legacy medical devices

There are two issues that are not addressed in this guidance document:

  1. It is not clear if the current agreements with Turkey and Switzerland regarding the Directives will remain in place, even if no new agreements regarding the Regulations are reached. The guidance document does not address this point. For manufacturers currently relying on these seven Notified Bodies, this means uncertain times.
  2. But other manufacturers are also not safe. Currently there are 56 Notified Bodies designated for the MDD, while at the MDCG stakeholders meeting of September 30th, 2019 it was revealed that 39 of these current Notified Bodies also seek designation under the MDR. That means that the future CE Mark certifications for medical devices of 17 Notified Bodies is unclear. Seven of these entities are based in Turkey and Switzerland, but there are still 10 organizations of which it is far from certain whether they will remain available for surveillance activities for AIMDD and MDD certificates active after May 26, 2020. There is no information available about which Notified Bodies these would be, although it appears likely Notified Bodies designated for the MDR will also remain active for the Directives.

All this means that many companies cannot fully rely on the continuity of their certifications, unless they have already certified their devices under the MDR. It is recommended that manufacturers communicate well with their Notified Bodies, follow developments and prepare their legacy files for an early transition to the MDR.

Learn more about European MDR and Notified Body regulatory issues at Emergo by UL:

  • European MDR preparation and resource center
  • On-site EU MDR training for medical device manufacturers
  • Whitepaper: How to select or change your European Notified Body